FDA Clears Bevespi Aerosphere for COPD

Megan Brooks

Disclosures

April 27, 2016

The US Food and Drug Administration (FDA) has approved the first long-acting muscarinic antagonist/long-acting beta-2 agonist combination in a pressurized metered-dose inhaler (pMDI), using novel co-suspension technology for chronic obstructive pulmonary disease (COPD), according to an AstraZeneca release.

Bevespi Aerosphere is a twice-daily fixed-dose combination of the long-acting muscarinic antagonist glycopyrrolate (9 μg) and the long-acting beta-2 agonist formoterol fumarate (4.8 μg) and is indicated for the long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. It is not indicated to treat asthma or to relieve acute bronchospasm.

Co-Suspension Technology

Bevespi Aerosphere is the first FDA-approved product using AstraZeneca's co-suspension technology. The technology uses porous, low-density phospholipid particles designed to form a uniform suspension inside the pMDI and more uniform drug distribution throughout the lungs, the company explains in its news release.

"It is important to determine the most appropriate delivery device for each individual patient, and we believe delivering combination therapies in a single pressurized metered dose device is an important option for physicians and patients. The technology is an essential piece of this, as it addresses issues often seen when multiple drugs are combined in a pMDI," Tosh Butt, vice president, US Respiratory, AstraZeneca, noted in email to Medscape Medical News.

"Co-suspension technology provides a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time, as well as preventing drug crystals from interacting with one another, thus allowing for consistent dosing of one or more different drugs from a single pMDI," he added.

The FDA approved Bevespi Aerosphere based on data from the PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3. Overall, the pivotal trial program enrolled more than 3700 patients with moderate to very severe COPD.

Twice-daily Bevespi Aerosphere was shown to significantly improve lung function, as measured by change from baseline in morning predose trough forced expiratory volume in 1 second at 24 weeks (P < .001) vs its individual components (glycopyrrolate 9 μg and formoterol fumarate 4.8 μg) and placebo, the company said. Significant improvement in the secondary endpoints of peak forced expiratory volume in 1 second within 2 hours postdose and use of rescue medication were also observed.

The most common adverse events with Bevespi Aerosphere (≥2% incidence and more common than with placebo) were urinary tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7% with placebo).

Complete prescribing information and a medication guide are available on the AstraZeneca website.

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